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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pack, heat, moist
Product CodeIMA
Regulation Number 890.5730
Device Class 1


Premarket Reviews
ManufacturerDecision
RACHEL'S REMEDIES, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 6 6
2017 1 1
2018 2 2
2019 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fire 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Burst Container or Vessel 2 2
Overheating of Device 2 2
Improper or Incorrect Procedure or Method 2 2
Sparking 1 1
Failure to Power Up 1 1
Break 1 1
Device Emits Odor 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 3 3
Full thickness (Third Degree) Burn 3 3
No Information 1 1
No Code Available 1 1
Burn, Thermal 1 1
Partial thickness (Second Degree) Burn 1 1
Burn(s) 1 1
Skin Irritation 1 1
Burning Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bruder Healthcare Company, LLC II Mar-22-2024
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